A Study to Assess the Efficacy of Raltegravir, Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen)

HIV-1 Infection Clinical Trial

— WIP  

Official title:

A Non-interventional Cohort Study for the Assessment of the Efficacy of RALTEGRAVIR 400 mg Administered Twice Daily in Combination With Other Antiretroviral Drugs to Treat Infection With the Human Immunodeficiency Virus 1 (HIV-1) in Adults and Aging Patients (≥ 50 Years) Under Conditions That Are Representative of the Nationwide Treatment of HIV-positive Patients in Germany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213316
• Other study ID #: 0518-145
• Status: Completed
• Phase: N/A
• First received: September 30, 2010
• Last updated: May 11, 2015
• Start date: October 2010
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

This is an observational, non-comparative, multicenter, open-label study. Participants will be treated with Raltegravir according to standard clinical practice, and monitored over a total period of 96 weeks. In an extension to the study (Amendment 1), a new cohort of aging participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks. Participants who stop taking Raltegravir before the end of the 96-week period or 48-week period, respectively, will be followed up for 3 months after discontinuing the drug. The primary objective is to determine the proportion of participants with a human immunodeficiency virus (HIV)-1 viral load < 50 copies/mL after 48 weeks of treatment with Raltegravir.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

The prospective participant must meet, at least, all of the criteria below to be eligible for study participation. The participant:

• Is a minimum age of 18 years (adults) or 50 years (aging participants);

• Is male or female;

• Has confirmed infection with HIV-1 (positive HIV test according to appropriate standard practice;

• Has commenced antiretroviral treatment with Raltegravir according to the recommendations made in the Summary of Product Characteristics at the time of enrollment on the study, or a maximum 6 months prior to enrollment on the study;

• Has any cluster of differentiation (CD4) cell (specialized white blood cell) count upon enrollment on the study.

Exclusion criteria

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation. The participant:

• For which Raltegravir, or its ingredients, are contraindicated;

• Has intolerance to Raltegravir, or its ingredients;

• If female, is pregnant, breastfeeding, or are planning a pregnancy or egg donation during the study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV-1 Infection
• Immunologic Deficiency Syndromes
• Infection

Intervention

Drug:
• Raltegravir
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 weeks
• Raltegravir
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of participants with an HIV-1 viral load < 50 copies/mL after 48 weeks of Raltegravir treatment		48 weeks	No
Primary	The proportion of aging participants with an HIV-1 viral load < 50 copies/mL after 48 weeks of Raltegravir treatment		48 weeks	No
Secondary	The proportion of participants with an HIV-1 viral load < 50 copies/mL after 96 weeks of Raltegravir treatment		96 weeks	No
Secondary	HIV-1 viral load in participants over a period of 96 weeks		96 weeks	No
Secondary	Change from Baseline in CD4+ T-cell counts over a period of 96 weeks		Baseline and 96 weeks	No
Secondary	HIV-1 viral load in aging participants over a period of 48 weeks		48 weeks	No
Secondary	Change from Baseline in CD4+ T-cell counts in aging participants over a period of 48 weeks		48 Weeks	No
Secondary	Framingham Risk Scores for cardiovascular disease in aging participants and changes from baseline		Baseline and 48 weeks	No
Secondary	Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Scores for cardiovascular disease in aging participants and changes from baseline		Baseline and 48 weeks	No
Secondary	Number of aging participants with a comorbidity		48 weeks	No
Secondary	Number of aging participants taking a concomitant medication		48 weeks	No